NCT02515864

Brief Summary

A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 healthy

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

July 29, 2015

Last Update Submit

September 7, 2017

Conditions

Healthy

Keywords

Male and Female Volunteers

Outcome Measures

Primary Outcomes (1)

  • QT/QTc Interval

    24 hours

Study Arms (4)

FYU-981 anticipated therapeutic dose

EXPERIMENTAL

Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)

Drug: FYU-981Drug: PlaceboDrug: Moxifloxacin Placebo

FYU-981 supratherapeutic dose

EXPERIMENTAL

Drug: FYU-981, Moxifloxacin Placebo (Oral)

Drug: FYU-981Drug: Moxifloxacin Placebo

Placebo

PLACEBO COMPARATOR

Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral)

Drug: PlaceboDrug: Moxifloxacin Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin, FYU-981 Placebo (Oral)

Drug: PlaceboDrug: Moxifloxacin

Interventions

FYU-981DRUG
FYU-981 anticipated therapeutic doseFYU-981 supratherapeutic dose
PlaceboDRUG
FYU-981 anticipated therapeutic doseMoxifloxacinPlacebo
MoxifloxacinDRUG
Moxifloxacin
Moxifloxacin PlaceboDRUG
FYU-981 anticipated therapeutic doseFYU-981 supratherapeutic dosePlacebo

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese adult subjects
  • Body mass index: \>=18.5 and \<27.5

You may not qualify if:

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Japan, Kanagawa, Japan

Location

MeSH Terms

Interventions

dotinuradMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 5, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

November 1, 2016

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

JP(1)